DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
In the response dated June 17th, 2026, Applicant amended claims 1, 3, 4, 6, 7, 10, 12, 13, and 16. Claims 14, 15, 17, and 20 are canceled. Claims 1-13, 16, 18, 19, and 21-24 are pending.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 17th, May 7th, and October 17th, 2025 is being considered by the examiner.
Priority
Acknowledgment is made of applicant’s claim for priority. The current application claims benefit of provisional application 63539774, filed on September 21st, 2023.
Response to Arguments
In response to the argument put forward in the amendment, Examiner will address them in the order they were presented.
Regarding page 7, Applicant’s arguments have been considered. The claim objections and rejections under 35 USC 112 are withdrawn.
Regarding page 8, Applicant’s amendments merit new grounds for rejection in view of the Rondoni reference. Rondoni further teaches “wherein each of the first row, the second row, and the third row comprises two or more of the electrodes, wherein the second row is disposed between the first and third rows [i.e., inner electrodes (313A-C) between (323A-C) and (333A-C)]; a lead body coupled to the cuff; ([0080] “wires extend through/within the lead body 82 up to and through the length of the cuff body 101”) and a plurality of first conductors extending through the lead body and the cuff with the first conductors electrically coupled to the electrodes. (see [0080] above and [0119] “electrodes 323A, 323B, 323C are electrically common with each other” using conducting elements) wherein, within the cuff or lead body, each electrode in the first and second rows is electrically coupled to a different one of the first conductors and each electrode in the third row is electrically coupled to the same one of the first conductors as an opposing one of the electrodes in the first row. ([0119] “electrodes 323A, 323B, 323C are electrically common with each other in the circumferential orientation” as opposed to the linear row)”
Applicant’s arguments have been considered but are not persuasive. Applicant argues that the Rondoni does not teach the “each electrode in the first and second rows is electrically coupled to a different one of the first conductors and each electrode in the third row is electrically coupled to the same one of the first conductors as an opposing one of the electrodes in the first row” because paragraph [0119] of Rondoni discloses that all of the electrodes of a row (e.g., the row containing electrodes (333A-C) are coupled in common (i.e., to the same conductor)). The full sentence of Rondoni discloses “[0119] In some examples, the array 332 of outer electrodes 323A, 323B, 323C are electrically common with each other in the circumferential orientation”, not in a row. This indicates electrodes are electrically coupled across rows, depending on linear or circumferential orientation. Furthermore, the orientation of Rondoni is adjustable and can comprise multiple formats of condition. While these claims are now directed to a different scope of subject matter, Examiner maintains that the claims are taught by Rondoni.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 3-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rondoni et al. (US20220233863).
The following figures from Rondoni’s specification will be referenced for the purposes of applying art.
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Regarding claim 1, Rondoni teaches an electrical stimulation lead [i.e., a cuff electrode (300)] comprising: a cuff (300) comprising a cuff body (301) having an exterior surface [i.e., outer electrodes (333B)] and an interior surface [i.e., inner electrodes (313B)], and a plurality of electrodes disposed on the interior surface of the cuff body [i.e., inner electrodes (313A-C)] and arranged into at least three rows of electrodes [i.e., inner electrodes (323A-C), (313A-C), and (333A-C)], wherein the at least three rows comprises a first row [i.e., inner electrodes (323A-C)], a second row [i.e., inner electrodes (323A-C), and a third row [i.e., inner electrodes (333A-C)], wherein each of the first row, the second row, and the third row comprises two or more of the electrodes, wherein the second row is disposed between the first and third rows [i.e., inner electrodes (313A-C) between (323A-C) and (333A-C)]; a lead body coupled to the cuff; ([0080] “wires extend through/within the lead body 82 up to and through the length of the cuff body 101”) and a plurality of first conductors extending through the lead body and the cuff with the first conductors electrically coupled to the electrodes. (see [0080] above and [0119] “electrodes 323A, 323B, 323C are electrically common with each other” using conducting elements) wherein, within the cuff or lead body, each electrode in the first and second rows is electrically coupled to a different one of the first conductors and each electrode in the third row is electrically coupled to the same one of the first conductors as an opposing one of the electrodes in the first row. ([0119] “electrodes 323A, 323B, 323C are electrically common with each other in the circumferential orientation” as opposed to the linear row)
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Regarding claim 3, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches wherein the first, second, and third rows have four electrodes each or six electrodes each. ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”)
Regarding claim 4, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches the electrical stimulation lead of claim 1, wherein the first and third rows have n electrodes each and the second row has N-2n electrodes, wherein N is a total number of the electrodes in a plurality of electrodes and n is less than N. ([Fig. 5a] electrodes (250A-C) comprise N-2n electrodes while 252B and 254B comprise n electrodes)
Regarding claim 5, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches wherein the at least three rows further comprise a fourth row and a fifth row, wherein the first, second, and third rows are all disposed between fourth and fifth rows. ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix” where rows are disposed interchangeably)
Regarding claim 6, Rondoni teaches all of the limitations of claim 5. Rondoni also teaches wherein the first and third rows have n electrodes each, the fourth and fifth rows have m electrodes each, and the second row has N-2n-2m electrodes, wherein N is a total number of the electrodes in the plurality of electrodes, n is less than N, m is less than N, and 2n-2m is less than N. ([Fig. 11] electrodes 323A-323C, 313A-313C, 333A-333C and ring electrodes 415A, 415B)
Regarding claim 7, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches wherein the cuff further comprises a plurality of second conductors, wherein each of the second conductors electrically couples one of the electrodes of the first row to the opposing one of the electrodes of the third row. ([0120] “the first array 332 of outer electrodes 323A, 323B, 323C are electrically common with each other in the circumferential orientation”; see also [0143] “the elongate electrode 520 is common axially to all of the other electrodes 323B-323C, 313B-313C, and 333B-333C of array 530.”)
Regarding claim 8, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches an electrical stimulation system, comprising: the electrical stimulation lead of claim 1 (see [Fig. 8a] above); and a control module ([0064] “implantable pulse generator”) configured to receive a portion of the lead body of the electrical stimulation lead and to electrically couple to the electrodes of the cuff. ([0064] “lead extending between the cuff electrode and implantable pulse generator”)
Regarding claim 9, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches a method of electrically stimulating a patient, the method comprising ([abstract] “methods of making and using a cuff electrode”): providing the electrical stimulation lead of claim 1 implanted within the patient (see [Fig. 8a] above); and applying electrical current through the patient with at least one of the electrodes of each of the first and third rows having a first polarity and at least one of the electrodes of the second row having a second polarity opposite the first polarity. ([0106-0107] “FIGS. 7A-7K also may be viewed as schematically representing at least an example method of neurostimulation… electrodes 103A, 103C act as anodes while the inner electrode 103B (same as 113B) acts as a cathode”)
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 10-13 and 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Rondoni et al. (US20220233863) as applied to claim 1 above.
Regarding claim 2, Rondoni teaches all of the limitations of claim 1. Rondoni also teaches wherein each of the electrodes of the second row are staggered relative to the electrodes of the first and third rows. ([Fig. 25] where pattern of electrodes (4682), (4684), and (4686) are staggered electrode rows; see also [0241] “the array may comprise a greater number or a fewer number of electrodes than shown in FIG. 25”). Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims. Therefore, it would have been prima facie obvious to have combined various embodiments of Rondoni to have a variety of electrode arrays while accommodating a stimulation device’s necessary array for the different patient’s nerve sizes.
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The following figure from Rondoni’s specification will be referenced for the purposes of applying art.
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Regarding claim 10, Rondoni teaches the electrical stimulation lead of claim 1, [i.e., a cuff electrode (500)] wherein each of electrodes in the second row is at least twice as long as each of the electrodes of the first and third rows (inner electrode (520) between (313B, 323B, 333B) and (339A-C) in Fig. 12 and 13A); It would have been prima facie obvious to enlarge the electrodes of the second row of array 330 to at least twice the size of the first and third rows electrodes, as taught by Rondoni’s other embodiments, with a reasonable expectation of success, for the purpose of “permit[ting] use of lower stimulation amplitudes via the relatively larger surface areas” [0145].
Rondoni’s disclosure teaches the variety of electrode arrays in electrical stimulation cuffs, in part, by explaining “it will be understood that size, shape, and/or pattern of electrodes … in FIG. 25 is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown” [para 0241]. “As noted above… a greater number or fewer number of electrodes may comprise the array” [para 0244]. Rondoni indicates that these patterns are dictated by art recognized results since “the various nerve fiber groups may have different diameters from each other and/or may have positions within the nerve casing which vary from the positions shown in FIG. 6A.” Thus, Rondoni indicates the variety of electrode arrays encompasses design choices for the user.
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The previous figure from Rondoni’s specification will be referenced for the purposes of applying art.
Regarding claim 11, Rondoni teaches all of the limitations of claim 10. Rondoni also teaches wherein the at least three rows further comprises a fourth row… wherein the fourth row comprises at least one of the electrodes ([Fig. 11] where electrodes (415A-B) can either be between electrodes (313A-C), (323A-C), and (333A-C) or outside of it when the cuff is unwrapped). Rondoni does not explicitly teach a fourth row disposed between the first and third rows. Rondoni does illustrate the different arrangements when teaching [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”). Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims. Therefore, it would have been prima facie obvious to have combined various embodiments of Rondoni to have a variety of electrode arrays while accommodating a stimulation device’s necessary array for the different patient’s nerve sizes.
Regarding claim 12, Rondoni teaches all of the limitations of claim 11. Rondoni also teaches wherein the at least three rows further comprises a fifth row not disposed between the first and third rows wherein the fifth row comprises at least one of the electrodes, ([Fig. 11] where electrodes (415A-B) can either be between electrodes (313A-C), (323A-C), and (333A-C) or outside of it when the cuff is unwrapped) Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
Regarding claim 13, Rondoni teaches all of the limitations of claim 10. Rondoni also teaches wherein the at least three rows further comprises a fourth row that is not disposed between the first and third rows wherein the fourth row comprises at least one of the electrodes, ([Fig. 11] where electrodes (415A-B) can either be between electrodes (313A-C), (323A-C), and (333A-C) or outside of it when the cuff is unwrapped) Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
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The following figure from Rondoni’s specification will be referenced for the purposes of applying art.
Regarding claim 16, Rondoni teaches an electrical stimulation lead [i.e., a cuff electrode (500)] of claim 1. Rondoni does not explicitly teach and comprises more of the electrodes than the first row and more of the electrodes than the third row, wherein each of the electrodes in the first and third rows is at least twice as long as each of the electrodes of the second row Rondoni does illustrate the different arrangements when teaching ([Fig. 11] where electrodes (415A-B) can either be between electrodes (313A-C), (323A-C), and (333A-C) or outside of it when the cuff is unwrapped; see also ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) and [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”). Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
Regarding claim 18, Rondoni teaches all of the limitations of claim 16. Rondoni does not explicitly teach wherein the at least three rows further comprises a fourth row that is not disposed between the first and third rows. Rondoni does illustrate the different arrangements when teaching ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) and [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”). Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
Regarding claim 19, Rondoni teaches all of the limitations of claim 16. Rondoni does not explicitly teach wherein the at least three rows further comprises a fourth row that is disposed between the first and third rows. Rondoni does illustrate the different arrangements when teaching ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) and [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”)Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
Regarding claim 21, Rondoni teaches all of the limitations of claim 11. Regarding claim 21, Rondoni also teaches wherein the at least three rows further comprises a fifth row that is between the second and fourth rows, wherein the fifth row comprises at least one of the electrodes. Rondoni illustrates the different arrangements when teaching ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) and [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
Regarding claim 22, Rondoni teaches all of the limitations of claim 11. Regarding claim 22, Rondoni also teaches wherein each electrode of the fourth row is at least twice as long as each of the electrodes of the first and third rows. Rondoni does illustrate the different arrangements when teaching ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) and [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
Regarding claim 23, Rondoni teaches all of the limitations of claim 12. Regarding claim 23, Rondoni also teaches wherein each electrode of the fifth row is at least twice as long as each of the electrodes of the first and third rows. Rondoni does illustrate the different arrangements when teaching ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) and [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
Regarding claim 24, Rondoni teaches all of the limitations of claim 13. Regarding claim 24, Rondoni also teaches wherein each electrode of the fourth row is at least twice as long as each of the electrodes of the first and third rows. Rondoni does illustrate the different arrangements when teaching ([0123] “cuff electrode 300 may comprise a 4×4, 3x5, 4×6, etc. electrode matrix”) and [0241], “it will be understood that size, shape, and/or pattern of electrodes … is merely one example, and that the electrodes … may have different sizes, shape, and/or patterns than shown”) Applicant’s specification does not disclose a criticality with any of the arrangements of the electrodes that are illustrated with the figures or consistent with the instant claims.
Additional Considerations
The prior art made of record and not relied upon that is considered pertinent to applicant’s disclosure can be found on PTO-892 of the prior office action.
Swanson et al. (Pat. US 9054436) describes how to make a medical stimulation lead with multiple small, separately controlled electrodes. The lead is especially aimed at deep brain stimulation, where precise targeting matters because the treatment area is small and nearby tissue should be avoided.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/R.A.S/Examiner, Art Unit 3792
/AMANDA L STEINBERG/Examiner, Art Unit 3792
